Efficacy of Eluxadoline in the Treatment of Irritable Bowel Syndrome With Diarrhea in Patients With Inadequate Control of Symptoms With Prior Loperamide Use

NCT ID: NCT02959983

Last Updated: 2019-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 346 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-10-25
• Study Completion Date: 2018-01-22

Brief Summary

This study will evaluate the efficacy and safety of eluxadoline 100 milligrams (mg) twice a day (BID) versus placebo for the treatment of patients with Irritable Bowel Syndrome with Diarrhea (IBS-D) who report that the use of loperamide in the prior 12 months failed to provide control of their IBS-D symptoms.

Conditions

Irritable Bowel Syndrome With Diarrhea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Eluxadoline

Eluxadoline 100 mg oral tablets twice daily (BID) with food for 12 weeks.

Group Type: ACTIVE_COMPARATOR

Eluxadoline

Intervention Type: DRUG

Eluxadoline 100 mg oral tablets BID with food.

Placebo

Placebo matching eluxadoline oral tablets BID with food for 12 weeks.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo matching eluxadoline oral tablets BID with food.

Interventions

Eluxadoline

Eluxadoline 100 mg oral tablets BID with food.

Intervention Type: DRUG

Placebo

Placebo matching eluxadoline oral tablets BID with food.

Intervention Type: DRUG

Other Intervention Names

VIBERZI™

Eligibility Criteria

Inclusion Criteria

• Has a diagnosis of IBS-D, defined by the Rome III criteria as loose (mushy) or watery stools ≥25% and hard or lumpy stools ≤25% of bowel movements.
• Has had a colonoscopy performed within 5 years prior to Screening if they are at least 50 years of age, OR if they meet any of the following alarm features:

1. Has documented weight loss within the past 6 months; or

2. Has nocturnal symptoms; or

3. Has a familial history of colon cancer; or

4. Has blood mixed with their stool (excluding any blood from hemorrhoids)

• Patient reports use of loperamide in the 12 months prior to Screening for IBS-D symptoms and that loperamide did not provide adequate control of IBS-D symptoms.
• Has not used any loperamide rescue medication within 14 days prior to randomization.

Exclusion Criteria

• Has a diagnosis of Irritable Bowel Syndrome (IBS) with a subtype of constipation IBS, mixed IBS, or unsubtyped IBS.
• Has a history of inflammatory or immune-mediated gastrointestinal (GI) disorders including inflammatory bowel disease (i.e., Crohn's disease, ulcerative colitis), microscopic colitis, or celiac disease.
• Has a history of diverticulitis within 3 months prior to screening.
• Has a documented history of lactose intolerance.
• Has a documented history of bile-acid malabsorption.
• Has a history of chronic or severe constipation or intestinal obstruction, stricture, toxic megacolon, GI perforation, fecal impaction, gastric banding, bariatric surgery, adhesions.
• Has any of the following surgical history:

1. Cholecystectomy or previously documented agenesis of gallbladder; or

2. Any abdominal surgery within the 3 months prior to screening; or

3. Major gastric, hepatic, pancreatic, or intestinal surgery (appendectomy, hemorrhoidectomy, or polypectomy greater than 3 months post-surgery are allowed).

• Has a history of cholecystitis within 6 months before screening.
• Has a history of pancreatitis or structural diseases of the pancreas, including known or suspected pancreatic duct obstruction.
• Has a history of known or suspected biliary duct obstruction or sphincter of Oddi disease or dysfunction, excluding a history of gallstones.
• Has a history or current evidence of laxative abuse within 5 years prior to screening.
• Has documented evidence of cirrhosis.
• Has a history of cardiovascular events, including stroke, myocardial infarction, congestive heart failure, or transient ischemic attack within 6 months prior to screening.
• Has an unstable renal, hepatic, metabolic, or hematologic condition.
• Has a history of malignancy within 5 years before screening (except squamous and basal cell carcinomas and cervical carcinoma in situ).
• Has a history of human immunodeficiency virus infection.
• Has a history of Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision-defined substance dependency, excluding nicotine and caffeine, within 2 years prior to screening.
• Has a history of alcohol abuse, alcohol addiction, and alcoholism or drinks more than 3 alcoholic beverages per day.
• Has used aspirin or aspirin-containing medications (>325 mg of aspirin per day) or nonsteroidal anti-inflammatory drugs, when taken specifically for the symptoms of IBS, within 14 days of randomization.
• Has current (within 14 days of randomization) or expected use of any narcotic or opioid-containing agents, tramadol, docusate, enemas, GI preparations (including antacids containing aluminum or magnesium, antidiarrheal agents [except loperamide rescue medication after randomization]), antinausea agents, antispasmodic agents, bismuth, or prokinetic agents.
• Has current (within 28 days of randomization) use of rifaximin or other antibiotics (with the exception of topical antibiotics or a 1-day course with an antibiotic). Expected use of rifaximin or other antibiotics during the course of the study that is known at the time of randomization.
• Has an elective surgery planned or expects to need elective surgery at any time during the study.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Allergan

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Esther Jo

Role: STUDY_DIRECTOR

Allergan

Locations

Clinical Research Associates, LLC

Huntsville, Alabama, United States

The Center for Clinical Trials

Saraland, Alabama, United States

Elite Clinical Studies

Phoenix, Arizona, United States

Arkansas Gastroenterology

North Little Rock, Arkansas, United States

Med Investigations

Carmichael, California, United States

GW Research Inc

Chula Vista, California, United States

Diagnamics Inc

Encinitas, California, United States

Behavioral Research Specialists, LLC

Irvine, California, United States

Providence Clinical Research

North Hollywood, California, United States

Shahram Jacobs MD INC.

Sherman Oaks, California, United States

Westlake Medical Research

Thousand Oaks, California, United States

Upland Clinical Research

Upland, California, United States

Advanced RX Clinicial Research Group, Inc.

Westminster, California, United States

Connecticut Clinical Research Foundation

Bristol, Connecticut, United States

Medical Research Center of Connecticut, LLC

Hamden, Connecticut, United States

Innovative Research of West Florida, Inc.

Clearwater, Florida, United States

Digestive Care of N. Broward

Coral Springs, Florida, United States

Homestead Medical Research

Homestead, Florida, United States

Clinical Neuroscience Solutions Inc.

Jacksonville, Florida, United States

Health Awareness, Inc.

Jupiter, Florida, United States

Precision Clinical Research LLC

Lauderdale Lakes, Florida, United States

Pharmax Research Clinic Inc.

Miami, Florida, United States

Well Pharma Medical Research, Corp.

Miami, Florida, United States

Ocean Blue Medical Research Center, Inc

Miami Springs, Florida, United States

Bravo Health Care Center

North Bay Village, Florida, United States

Clinical Neuroscience Solutions Inc.

Orlando, Florida, United States

Clinical Research of West Florida Inc.

Tampa, Florida, United States

Meridien Research

Tampa, Florida, United States

Emory University School of Medicine

Atlanta, Georgia, United States

RNA America, LLC

Buford, Georgia, United States

Northwestern University Feinbery School of Medicine

Chicago, Illinois, United States

Pharmakon Inc

Evergreen Park, Illinois, United States

Investigators Research

Brownsburg, Indiana, United States

Radiant Research, Inc.

Evansville, Indiana, United States

Clinical Research Advantage Inc/Radiant Research Inc.

Evansville, Indiana, United States

Gtc Research

Shawnee Mission, Kansas, United States

Investigative Clinical Research

Annapolis, Maryland, United States

MGG Group Co. Inc. Chevy Chase Clinical Research

Chevy Chase, Maryland, United States

MedVadis Research Corporation

Watertown, Massachusetts, United States

Clinical Research Insititute of Michigan LLC

Chesterfield, Michigan, United States

Gastroenterology Associates of Western Michigan, PLC

Wyoming, Michigan, United States

The Center for Clinical Trials

Biloxi, Mississippi, United States

Women's Clinic of Lincoln, P.C.

Lincoln, Nebraska, United States

Quality Clinical Research Inc.

Omaha, Nebraska, United States

Advanced Biomedical Research of America

Las Vegas, Nevada, United States

Advanced Research Institute

Reno, Nevada, United States

Drug Trials Brooklyn

Brooklyn, New York, United States

NY Scientific

Brooklyn, New York, United States

Long Island Gastrointestinal Group LLP

Great Neck, New York, United States

IMA Medical Research, PC

Kew Gardens, New York, United States

Charlotte Gastroenterology & Hepatology, PLLC

Charlotte, North Carolina, United States

Peters Medical Research LLC

High Point, North Carolina, United States

North State Clincial Research PLLC

Lenoir, North Carolina, United States

Wake Research Associates LLC

Raleigh, North Carolina, United States

Trial Management Associates, LLC

Wilmington, North Carolina, United States

Clinical Inquest Center Ltd

Beavercreek, Ohio, United States

Hometown Urgent Care and Research

Cincinnati, Ohio, United States

Buckeye Health and Research

Columbus, Ohio, United States

Hometown Urgent Care and Research

Columbus, Ohio, United States

Hometown Urgent Care and Research

Huber Heights, Ohio, United States

Central Sooner Research

Norman, Oklahoma, United States

The Oregon Center for Clinical Investigations, INC.

Salem, Oregon, United States

Partners in Clinical Research

Cumberland, Rhode Island, United States

WR-ClinSearch, LLC

Chattanooga, Tennessee, United States

New Phase Research & Development

Knoxville, Tennessee, United States

CNS Healthcare

Memphis, Tennessee, United States

Premier Family Physicians

Austin, Texas, United States

Family Medicine Associate of Texas

Carrollton, Texas, United States

Multi-Phase Trials LLC

San Antonio, Texas, United States

Health Texas Research Institute

San Antonio, Texas, United States

Discovery Clinical Trials - Stone Oak

San Antonio, Texas, United States

Carl Meisner Medical Clinic

Sugar Land, Texas, United States

Advanced Research Institute - Ogden

Ogden, Utah, United States

Wasatch Clinical Research, LLC

Salt Lake City, Utah, United States

Gastroenterology Associates of Northern Virginia

Fairfax, Virginia, United States

Blue Ridge Medical Research

Lynchburg, Virginia, United States

Corunna Medical Research Centre

Corunna, Ontario, Canada

Manna Research

Etobicoke, Ontario, Canada

SKDS Research Inc

Newmarket, Ontario, Canada

University of Calgary

Calgary, , Canada

Viable Clinical Research Corp.

Nova Scotia, , Canada

Centre de reserche St Louis

Québec, , Canada

Dynamik Research Inc

Québec, , Canada

Countries

United States; Canada

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

http://www.allerganclinicaltrials.com

More Information

Other Identifiers

CMO-US-GI-0429

Identifier Type: -

Identifier Source: org_study_id